Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Greene & Kellogg, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833495 | BUNN MICRO OXYGEN CONCENTRATOR | Greene & Kellogg, Inc. | 1983-11-29 | 53 | 0 |
| K830046 | MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY | Greene & Kellogg, Inc. | 1983-02-07 | 28 | 0 |
| K811155 | MODEL RXO2 OXYGEN RICH AIR SUPPLY | Greene & Kellogg, Inc. | 1981-05-05 | 7 | 0 |
| K800534 | MODEL 52 BUNN DRY AIR SUPPLY | Greene & Kellogg, Inc. | 1980-03-25 | 18 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda